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New Drugs And Therapeutic Biologics Approved In 2016

Executive Summary

Interactive chart of 2016 novel approvals from US FDA's Center for Drug Evaluation and Research.

FDA's Center for Drug Evaluation and Research approved 22 new molecular entities and novel therapeutic biologics in 2016.

The approvals chart below can be searched and sorted. Click on a column header to sort by that parameter, including sponsor, approval date, indication, and designations. Use the "search" box to filter the data. Searching by "priority" or "orphan," for example, will display only priority review or orphan drug approvals. To keep the size of the chart in check, breakthrough therapy designations are listed as "BTD" and products approved under accelerated approval regulations are designated "AA."

The Pink Sheet keeps ongoing track of new drug and therapeutic biologic approvals on the FDA Performance Tracker's Novel CDER Approvals page.

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